The Hi-Dow TrueStim Genesys PEMF Wraps finally hit the Market
This is a combination unit with PEMF, TENS, EMS, Heating Coil, and you pay for that flexibility in function, $4,999 .
This unit first showed up as ILX/IRT 510k Clearance in 12/2020,
Device Classification Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
510(K) Number K202337
Device Name Pulsed Electromagnetic Field Wrap
Applicant Hi-Dow International Inc.
2555 Metro Blvd
Maryland Heights, MO 63043
And on the FDA GUDID database in January for 4 devices,
TrueStim - 00851640007917
Pulsed Electromagnetic Field Wrap, Black, Knee Wrap
Company Name: Hi-Dow International Incorporated
Version or Model: HD-08B(TSG-B1)
Commercial Distribution Status: In Commercial Distribution
Device IDs: 00851640007917 (Primary)
GMDN Terms: Short-wave diathermy treatment system, home-use
As it was Cleared under an ILX Product Code it is a Prescription Device.
Hi-Dow initially said it was not going to be available to Retail Customers, only Health Insurance Companies, but it looks like that has changed.
Hi-Dow is a TENS/EMS company with no experience in PEMF so I am speculating that they went to the company with the most experience in Wearable PEMF, BIEL, to make their PEMF module.
If correct this could mean that BIEL has a higher powered, adjustable, rechargeable device in their portfolio.
This could also explain the mysterious 'Other Income' entries of $151k in Q4 2020, possible development cost, and $66k in Q2 2021, possible biannual licensing fee.
It will be interesting to see what Hi-Dow can do with this Genesys line. They have been successful in getting Insurance Company coverage for TENS/EMS units.
Exciting times at BIEL!!
https://www.truestim.com/shop/knee-wrap-genesys-pemf/
https://www.truestim.com/shop/neck-wrap-genesys-pemf/
https://www.truestim.com/shop/shoulder-wrap-genesys-pemf/
https://www.truestim.com/shop/true-wrap-genesys-pemf/
DESCRIPTION
PEMF True Wrap by TrueStim increases blood flow, lymph flow, and nitric oxide while reducing swelling, inflammation, and pain.
PEMF uses integrated therapeutic heat to help you recover faster shortening the amount of time that you spend in pain therapy.
PEMF is a drug-free alternative to surgery and other pain management treatments. Treat. Recover. Prevent. with PEMF from TrueStim.
This is a combination unit with PEMF, TENS, EMS, Heating Coil, and you pay for that flexibility in function, $4,999 .
This unit first showed up as ILX/IRT 510k Clearance in 12/2020,
Device Classification Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
510(K) Number K202337
Device Name Pulsed Electromagnetic Field Wrap
Applicant Hi-Dow International Inc.
2555 Metro Blvd
Maryland Heights, MO 63043
And on the FDA GUDID database in January for 4 devices,
TrueStim - 00851640007917
Pulsed Electromagnetic Field Wrap, Black, Knee Wrap
Company Name: Hi-Dow International Incorporated
Version or Model: HD-08B(TSG-B1)
Commercial Distribution Status: In Commercial Distribution
Device IDs: 00851640007917 (Primary)
GMDN Terms: Short-wave diathermy treatment system, home-use
As it was Cleared under an ILX Product Code it is a Prescription Device.
Hi-Dow initially said it was not going to be available to Retail Customers, only Health Insurance Companies, but it looks like that has changed.
Hi-Dow is a TENS/EMS company with no experience in PEMF so I am speculating that they went to the company with the most experience in Wearable PEMF, BIEL, to make their PEMF module.
If correct this could mean that BIEL has a higher powered, adjustable, rechargeable device in their portfolio.
This could also explain the mysterious 'Other Income' entries of $151k in Q4 2020, possible development cost, and $66k in Q2 2021, possible biannual licensing fee.
It will be interesting to see what Hi-Dow can do with this Genesys line. They have been successful in getting Insurance Company coverage for TENS/EMS units.
Exciting times at BIEL!!
https://www.truestim.com/shop/knee-wrap-genesys-pemf/
https://www.truestim.com/shop/neck-wrap-genesys-pemf/
https://www.truestim.com/shop/shoulder-wrap-genesys-pemf/
https://www.truestim.com/shop/true-wrap-genesys-pemf/
DESCRIPTION
PEMF True Wrap by TrueStim increases blood flow, lymph flow, and nitric oxide while reducing swelling, inflammation, and pain.
PEMF uses integrated therapeutic heat to help you recover faster shortening the amount of time that you spend in pain therapy.
PEMF is a drug-free alternative to surgery and other pain management treatments. Treat. Recover. Prevent. with PEMF from TrueStim.
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